CONTROL FOR PROTEIN-BASED ASSAY
A method for producing a positive antigen-based control for detecting a pathogen which includes providing a culture fluid having a pathogen with a first detectable antigen, wherein the culture fluid has a first concentration of the first detectable antigen, and exposing the culture fluid to UV electromagnetic irradiation for a time period sufficient to render the pathogen inactivated, thereby producing a positive antigen-based control, wherein the positive antigen-based control has a second concentration of the first detectable antigen that is no more than about 50% different from the first concentration when determined via ELISA. Also described are positive antigen-based controls and kits having the same.
1 . A method for producing a positive antigen-based control for detecting a pathogen, comprising:
providing a culture fluid comprising a pathogen having a first detectable antigen, wherein the culture fluid has a first concentration of the first detectable antigen; and
exposing the culture fluid to electromagnetic irradiation for a time period sufficient to render the pathogen inactivated, thereby producing a positive antigen-based control,
wherein the positive antigen-based control comprises a second concentration of the first detectable antigen that is no more than about 50% different from the first concentration when determined via ELISA.
2 . The method of claim 1 , wherein the pathogen comprises a virus.
3 . The method of claim 2 , wherein the virus comprises SARS-CoV-2, RSV, Flu A, Flu B, or a combination thereof.
4 . The method of claim 3 , wherein the detectable target antigen comprises a nucleocapsid protein.
5 . The method of claim 1 , wherein the electromagnetic irradiation comprises UV irradiation provided by UV-C light.
6 . The method of claim 1 , further comprising combining the culture fluid with a protease inhibitor.
7 . The method of claim 6 , wherein the positive antigen-based control comprises the protease inhibitor.
8 . The method of claim 1 , further comprising combining the positive antigen-based control with a protease inhibitor.
9 . The method of claim 1 , wherein the time period is between about 1 and 15 minutes.
10 . A kit comprising:
a positive antigen-based control, the positive antigen-based control comprising an inactivated pathogen; and
at least two quantification values.
11 . The kit of claim 10 , wherein the pathogen comprises a virus.
12 . The kit of claim 11 , wherein the virus comprises SARS-CoV-2, RSV, Flu A, Flu B, or a combination thereof.
13 . The kit of claim 10 , wherein the at least two quantification values comprise a TCID 50 value of the pathogen prior to inactivation and a concentration of a detectable target antigen.
14 . The kit of claim 10 , wherein the virus comprises SARS-CoV-2, and wherein the detectable target antigen is a nucleocapsid protein.
15 . The kit of claim 11 , further comprising a protease inhibitor.
16 . The kit of claim 11 , wherein the inactivated pathogen is provided in a fluid.
17 . A positive antigen-based control for detecting a pathogen, wherein the positive antigen-based control is provided by a method comprising:
providing a culture fluid comprising a pathogen, wherein the culture fluid has a detectable target antigen at a first concentration; and
exposing the culture fluid to electromagnetic irradiation for a time period sufficient to render the pathogen inactivated, thereby producing the positive antigen-based control,
wherein the positive antigen-based control comprises a second concentration of the detectable target antigen that is no more than about 50% different from the first concentration, and
wherein the first concentration and the second concentration are determinable via ELISA.
18 . The positive antigen-based control of claim 17 , wherein the pathogen comprises a virus.
19 . The positive antigen-based control of claim 18 , wherein the virus comprises SARS-CoV-2, RSV, Flu A, Flu B, or a combination thereof.
20 . The positive antigen-based control of claim 19 , wherein the detectable target antigen comprises a nucleocapsid protein.